Type 2 Diabetes MellitusPhase 2NCT00532506
Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
A Phase 2 study testing SK-0403 in people with Type 2 Diabetes Mellitus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 10 sites in Japan.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SK-0403
- How many people
- Not given
- Where
- 10 sitesJapan
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment-naive subjects diagnosed with type 2 diabetes mellitus
- Stable diet program for at least 8 weeks
- Criteria for HbA1c are met
Who cannot join
- Type 1 diabetes
- Patients treated with other antidiabetic drugs or Insulin
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Study site
Fukuoka
Study site
Gifu
Study site
Gunma
Study site
Hokkaido
Study site
Ibaraki
Study site
Kanagawa
Study site
Kumamoto
Study site
Ōita
Study site
Okinawa
Study site
Tokyo
About this study
The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SK-0403
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-0403Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ryuzo Kawamori, M.D., Study chair, Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532506
- Sponsor's protocol ID
- DP1001
- Status last verified
- Oct 2008
- First submitted
- 19 Sep 2007
- Last updated
- 10 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00532506
- Acronym / sponsor ID
- DP1001
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment-naive subjects diagnosed with type 2 diabetes mellitus
- Stable diet program for at least 8 weeks
- Criteria for HbA1c are met
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Patients treated with other antidiabetic drugs or Insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SK-0403 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryuzo Kawamori, M.D. study chair
Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SK-0403 in people with Type 2 Diabetes Mellitus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2008.